Caldani, Cyril - International Haemovigilance Network
Caldani, Cyril - International Haemovigilance Network
Caldani, Cyril - International Haemovigilance Network
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
ROLE OF THE NATIONAL<br />
HAEMOVIGILANCE COMMITTEE.<br />
PERSPECTIVES OF<br />
HAEMOVIGILANCE IN FRANCE<br />
French health<br />
products safety<br />
agency<br />
<strong>Cyril</strong> CALDANI,<br />
Annick ALPEROVITCH,<br />
André LIENHART<br />
11 th EHS – Rome 2009
French haemovigilance network<br />
National<br />
Regional<br />
Local<br />
EFS and<br />
CTSA<br />
Regional blood<br />
establishments:<br />
17 HvC<br />
Local blood<br />
centers: 150<br />
HvC<br />
Ministry of Health<br />
Afssaps<br />
National<br />
haemovigilance<br />
committee<br />
RHC: 24<br />
Regional<br />
haemovigilance<br />
coordinators<br />
Hospitals and hospital<br />
blood banks:<br />
1600 HvC, TC<br />
Healthcare professionals<br />
InVS<br />
Donors epidemiology<br />
2 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
The National <strong>Haemovigilance</strong><br />
Committee<br />
NHvC = advisory board that advises the<br />
Afssaps and the MoH on the field of<br />
haemovigilance<br />
• Representatives of the MoH, of the Afssaps, of<br />
the EFS and CTSA.<br />
• Experts in transfusion domains: anaesthesia,<br />
ICU, haematology, immunology, infectiology,<br />
virology, blood collection, testing, processing<br />
and distribution of blood and blood components.<br />
• Experts in epidemiology, in transfusion<br />
medicine.<br />
• <strong>Haemovigilance</strong> correspondents, regional<br />
haemovigilance coordinators.<br />
• Nurse, inspector.<br />
• Representative of blood donors, of customers<br />
3 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
Risk scale<br />
Disaster rate<br />
Under transfusion<br />
(haemorrhagic surgery)<br />
10 - 4<br />
10 - 3 HCV<br />
10 - 5<br />
10 - 6<br />
HIV<br />
HVB<br />
bacteria<br />
Allergy<br />
TRALI<br />
IBCT<br />
Overload<br />
10 - 7<br />
Product<br />
Product/Patient<br />
Clinical practice<br />
4 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
The “lamp-post effect”<br />
Guidelines<br />
Deviation<br />
Deviation<br />
5 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
Pulmonary edema WP<br />
ALI and circulatory overload<br />
• First cause of transfusion related death<br />
• Case study<br />
• Guidelines<br />
• Algorithm for diagnosis<br />
• CO<br />
• ALI<br />
• Other dyspnoea<br />
• Algorithm for imputability<br />
• TRALI<br />
• TACO<br />
6 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
TRALI/TACO: decision tree<br />
Respiratory<br />
effects<br />
N<br />
Pulmonary<br />
edema<br />
N<br />
TTBI WP<br />
Transfusion transmitted bacterial<br />
infection<br />
• Tools and guidelines to help the bacterial and<br />
clinical investigation<br />
• Advices on the cases<br />
• Collection of the bacterial strains at the Afssaps<br />
• Proposals of preventive measures<br />
• Publications<br />
8 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
TTBI: Approved laboratories<br />
9 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
Allergy WP<br />
Allergy<br />
• One of the most frequent ATR<br />
• Case analysis<br />
• Definition and classification<br />
• Guidelines for investigating severe allergic<br />
reactions to methylene blue treated FFP<br />
10 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
Deaths related to anaesthesia:<br />
Mechanism tree<br />
event leading to death<br />
419<br />
deaths totally or partially<br />
related to anaesthesia<br />
respiratory<br />
neurological<br />
cardiac<br />
vascular<br />
drugs<br />
central<br />
obstruction<br />
airway<br />
Impossible<br />
access<br />
lungs<br />
obstruction<br />
cement<br />
arrhythmia<br />
metabolic<br />
cardiogenic<br />
shock<br />
infarction<br />
true<br />
hypovolemia<br />
relative<br />
hypovolemia<br />
sepsis allergy sympath.<br />
Upper<br />
airway<br />
bronchos<br />
pasm<br />
trachea<br />
infection<br />
aspiration<br />
pulmonary<br />
embolism<br />
arrhythmia<br />
hypoxia<br />
anemia<br />
haemorrhage<br />
GA<br />
spinal<br />
39 49<br />
11 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009<br />
Lienhart 2006
Root causes analysis WP<br />
Systemic analysis<br />
• Systemic analysis<br />
• Individual errors<br />
• Core root causes of adverse events<br />
• Professional practices and hospital organization<br />
• Guidelines and training of haemovigilance<br />
correspondents and coordinators<br />
12 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
Conclusion<br />
Improvement in data quality<br />
Confidentiality and no blame policy<br />
Publication of the French<br />
haemovigilance data<br />
13 Role of NHvC. Perspectives of haemovigilance in France 11 th EHS – Rome 2009
Mephistopheles<br />
Blut ist ein ganz besonderer Saft<br />
Blood is a quite special juce<br />
Goethe, Faust<br />
Part I, scene IV<br />
from
Change language